Diverse role in a growing, innovative biotech company...
The organisation is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. Their lead product is Ruconest™ (Rhucin® in non-European territories) which is a recombinant human C1 inhibitor approved for the treatment of angioedema attacks in patients with HAE. They are also developing the same recombinant protein in other indications, including pre-eclampsia and acut...
As CQV Engineer you will arrange the commissioning, qualification and validation of all process equipment, facilities and utilities on the different sites (animal facilities, DSP and lab facilities) to ensure systems, facilities and equipment meet the design and performance requirements for users. Furthermore, you will coach the local team in the ongoing equipment re-qualification process, operations and performance requirements. Firstly, it is your responsibility to develop technical specificat...
• Bachelor’ or master’s degree in Biochemical Engineering, Chemical, Electrical, or Mechanical Engineering, Biotechnology or Life Sciences; engineering degree is preferred
• minimal 10 years of relevant working experience
• knowledgeable of Current Good Manufacturing Practices (cGMPs) and regulatory guidelines (EMA, FDA, ICH)
• a minimum of 5 years of cGMP CQV experience in different areas, like biotechnology, pharmaceutical production and laboratory
• experience with lean manufacturing pri...
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